Antifungal Treatment Advances

Medically reviewed | Published: | Evidence level: 1A
New antifungal treatments are expanding options for serious infections, including a July FDA label update allowing rezafungin use in eligible patients aged 12 and older. Clinical trial evidence and a Frontiers review show progress, while highlighting persistent gaps in resistance coverage, pediatric research, and access to diagnosis.
📅 Published:
Reviewed by iMedic Medical Editorial Team
📄 Pharmacology

Quick Facts

Rezzayo Age Eligibility
12 years and older
Rezzayo Administration
Once-weekly IV infusion
WHO Pipeline, September 2024
9 novel clinical candidates

Why are new antifungal treatments needed?

Quick answer: Drug resistance, treatment toxicity, and limited diagnostic access leave important gaps in care for invasive fungal infections.

Serious fungal infections pose particular problems for people whose immune defenses are weakened by cancer treatment, transplantation, or other illnesses. A review published in Frontiers in Cellular and Infection Microbiology on October 1, 2025, examines how resistance and the limitations of existing medicines are driving antifungal research. It brings together evidence on treatment strategies; it does not report a newly completed clinical trial. [Frontiers review](https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2025.1676009/full)

The World Health Organization’s first antifungal pipeline assessment illustrates the development challenge. Using data through September 30, 2024, it identified nine novel agents in clinical development and 22 products at the preclinical stage. These are historical pipeline counts, rather than a live inventory of September 2026 development. WHO also identified shortages of accessible diagnostic tests and pediatric treatment research. The implication is that better medicines must be accompanied by better ways to identify infections and determine which treatment is likely to work. [WHO pipeline assessment](https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/antifungal-agents-in-development), [WHO diagnostic and treatment findings](https://www.who.int/news/item/01-04-2025-who-issues-its-first-ever-reports-on-tests-and-treatments-for-fungal-infections)

What does rezafungin add to treatment for invasive candidiasis?

Quick answer: Rezafungin provides a weekly intravenous option for eligible patients with bloodstream or other invasive Candida infections.

Rezafungin, marketed as Rezzayo, belongs to the echinocandin class, which disrupts fungal cell-wall production. Its July 2026 FDA labeling includes adults and children aged 12 and older when treatment alternatives are limited or unavailable. The adolescent indication relies on adult studies and analyses predicting drug exposure; the label states that no pediatric clinical studies were conducted. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217417s007lbl.pdf)

The pivotal ReSTORE trial, published in The Lancet in 2023, randomized 199 adults to rezafungin or a comparator regimen beginning with caspofungin. Among participants in the primary efficacy analysis, approximately 59% receiving rezafungin and 61% receiving caspofungin met the combined cure endpoint at day 14. Rezafungin met the trial’s prespecified noninferiority criteria, meaning the results excluded a disadvantage larger than the chosen margin. They did not demonstrate superior cure rates or survival. The study was funded by Cidara Therapeutics and Mundipharma. [ReSTORE trial](https://doi.org/10.1016/S0140-6736(22)02324-8)

Weekly administration reduces infusion frequency, but patients still require clinical monitoring. The FDA label warns about serious allergic reactions, infusion reactions, sunlight sensitivity, and liver abnormalities. It also states that safety beyond four weekly doses has not been established. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217417s007lbl.pdf)

Can emerging antifungal therapies overcome drug resistance?

Quick answer: New targets and delivery methods may help, but their clinical value must be established for specific infections and patient groups.

The Frontiers review describes approaches including drugs aimed at additional fungal targets, combinations with complementary mechanisms, and delivery systems intended to improve drug penetration. Gene-editing tools can help researchers identify fungal vulnerabilities, while nanoparticles may help transport medicines to difficult infection sites. These approaches sit at different stages of development. Laboratory activity alone cannot establish that a treatment improves survival, avoids toxicity, or reaches an effective concentration in a patient. [Frontiers review](https://www.frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2025.1676009/full)

For Candida auris, CDC guidance shows why selecting treatment remains a practical challenge. Echinocandins are recommended as initial therapy for adult clinical infections, but resistant strains occur, and susceptibility testing is needed to guide care. A positive screening swab can indicate colonization—carrying the organism without illness—and does not by itself justify antifungal treatment. Accurate identification, specialist assessment, and infection-control measures therefore remain essential alongside drug development. [CDC clinical overview](https://www.cdc.gov/candida-auris/hcp/clinical-overview/index.html)

Frequently Asked Questions

No. Its U.S. indication covers candidemia and invasive candidiasis in eligible patients with limited treatment alternatives. It has not been studied for Candida infections involving heart valves, bone, or the meninges. [FDA prescribing information](https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217417s007lbl.pdf)

Not necessarily. Screening can detect colonization without infection. CDC recommends treating clinical infection rather than an isolated positive screening result, while maintaining appropriate precautions to prevent transmission. [CDC clinical overview](https://www.cdc.gov/candida-auris/hcp/clinical-overview/index.html)

References

  1. Liu D, Zhou R, Gao X. Recent innovations and challenges in the treatment of fungal infections. Frontiers in Cellular and Infection Microbiology. 2025;15:1676009. https://doi.org/10.3389/fcimb.2025.1676009
  2. World Health Organization. Antifungal preclinical and clinical pipeline review. Published April 2025; data through September 30, 2024. https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/antifungal-agents-in-development
  3. World Health Organization. WHO issues its first-ever reports on tests and treatments for fungal infections. April 1, 2025. https://www.who.int/news/item/01-04-2025-who-issues-its-first-ever-reports-on-tests-and-treatments-for-fungal-infections
  4. U.S. Food and Drug Administration. Rezzayo (rezafungin for injection): prescribing information. Revised July 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217417s007lbl.pdf
  5. Thompson GR III, et al. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial. The Lancet. 2023;401(10370):49–59. https://doi.org/10.1016/S0140-6736(22)02324-8
  6. Centers for Disease Control and Prevention. Clinical Overview of Candida auris. February 26, 2026. https://www.cdc.gov/candida-auris/hcp/clinical-overview/index.html